Regulatory Affairs Specialist

Regulatory Affairs at Cardinal Health

As a Regulatory Affairs Specialist, you will play a critical role in ensuring compliance with regulatory requirements for medical devices in Latin America. Your expertise will be instrumental in guiding product development, ensuring timely submissions, and maintaining regulatory approvals.

Key Responsibilities:

• Prepare and submit regulatory submissions to Cofepris and other relevant authorities.
• Develop regulatory strategies in collaboration with cross-functional teams.
• Liaise with external and internal stakeholders to gather necessary documentation and specifications.
• Maintain regulatory affairs documents and systems to ensure compliance and efficiency.

Requirements:

• Bachelor's degree in a scientific discipline or related field.
• Advanced proficiency in English and Spanish.
• 3+ years of experience in Regulatory Affairs for medical devices in Latin America.
• Proven track record of successful regulatory submissions and approvals for medical devices.

Cardinal Health is an equal opportunity employer and celebrates diversity in the workplace.